Back to resultsPilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum (BicMag)
Primary Purpose
End Stage Renal Failure on Dialysis, Vascular Calcification
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Magnesium
Bicarbonate
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Failure on Dialysis
Eligibility Criteria
Inclusion Criteria:
- Male or female hemodialysis patients ≥ 18 years of age
- Negative pregnancy test of female patients in child-bearing age
- The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
- Start of chronic hemodialysis treatment ≥ 3 months ago
- HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
- Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
- T50 ≥ 200 minutes.
Exclusion Criteria:
- Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
- History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
Sites / Locations
- University Hospital Bern Inselspital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mg first
Bicarbonate first
Arm Description
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Outcomes
Primary Outcome Measures
Effect of treatment on serum calcification propensity, measured by T50
T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Full Information
NCT ID
NCT02621762
First Posted
November 26, 2015
Last Updated
September 25, 2017
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02621762
Brief Title
Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
Acronym
BicMag
Official Title
Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis, Vascular Calcification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mg first
Arm Type
Experimental
Arm Description
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Arm Title
Bicarbonate first
Arm Type
Experimental
Arm Description
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Intervention Type
Device
Intervention Name(s)
Magnesium
Intervention Description
Magnesium in dialysate increased
Intervention Type
Device
Intervention Name(s)
Bicarbonate
Intervention Description
Bicarbonate in dialysate increased
Primary Outcome Measure Information:
Title
Effect of treatment on serum calcification propensity, measured by T50
Description
T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
111 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female hemodialysis patients ≥ 18 years of age
Negative pregnancy test of female patients in child-bearing age
The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
Start of chronic hemodialysis treatment ≥ 3 months ago
HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
T50 ≥ 200 minutes.
Exclusion Criteria:
Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Uehlinger, Prof Dr.med.
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bern Inselspital
City
Bern
State/Province
BE
ZIP/Postal Code
3008
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22956818
Citation
Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.
Results Reference
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Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
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